A Study to Assess the Safety of MEDI7836 in Healthy Adults.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Assess the Safety of MEDI7836 in Healthy Adults. (NCT02388347), a randomized phase 1 study. The primary outcome is Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs).

2. Clinical Question

3. Trial Design

This was a Phase 1a, randomized, placebo-controlled, double-masked, parallel-group study of MEDI7836 in healthy adults. The registry reports an enrollment of 79 and a completed study. Its listed study dates are 2015-03 for the start and 2016-01 for primary completion. Those dates describe the registry record and do not, on their own, provide detail about the timing of individual participant visits or data analysis.

The study evaluated a single ascending dose. Participants in each active-treatment group were to receive one subcutaneous MEDI7836 injection on Day 1; the placebo group was to receive one subcutaneous placebo injection on Day 1. The active groups are named MEDI7836 Dose 1, MEDI7836 Dose 2, MEDI7836 Dose 3, and MEDI7836 Dose 4. The actual dose amounts, escalation criteria, and operational details of dose escalation are not reported in the registry record.

Randomization and double masking are identified in the record, but the method used to generate the allocation sequence, allocation concealment, and the people or roles kept masked are not reported in the registry record. The allocation ratio and any stratification factors are also not reported. The record describes the study as parallel, meaning participants were assigned to a group rather than having each participant receive the active treatment and placebo in sequence.

The primary safety observation period extended from study-drug administration to 281 Days Postdose. The record also lists pharmacokinetic outcomes, including measures of exposure, concentration, clearance, half-life, time to maximum concentration, and apparent volume of distribution, as well as the percentage of participants positive for anti-drug antibodies. Although 13 outcome measures are listed, the record lists zero analyses. Detailed results for the pharmacokinetic and anti-drug-antibody outcomes are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: A total of 79 participants were screened. Of these, 32 participants were randomized and treated in the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: As Treated Population included all randomized participants and treated with MEDI7836 or placebo.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), measured over From Study Drug Administration to 281 Days Postdose.

The primary endpoint counts participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs). The registry defines an adverse event as an unfavourable and unintended sign, symptom, or disease temporally associated with use of a medicinal product, whether or not it is considered related to that product. An abnormal laboratory finding can also qualify. A serious adverse event is defined by outcomes such as death, initial or prolonged inpatient hospitalization, a life-threatening situation, persistent or significant disability or incapacity, or a congenital anomaly or birth defect in the offspring of a participant who received MEDI7836. The definition also allows an event to be considered serious for another significant reason.

For this endpoint, treatment-emergent events are events that were absent before treatment or worsened relative to the pretreatment state, during the period from administration through Day 281. Counting participants with events is a way to describe how many people in each group experienced an event during the stated observation period. Separating serious from other adverse-event counts can help distinguish event severity categories, while retaining the broader safety count.

These counts are descriptive. They do not by themselves establish that a treatment caused an event, nor do they show the event’s duration, recurrence, clinical course, or relationship to dose. The registry does not provide an inferential analysis for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a count of participants with TEAEs and TESAEs, with the unit specified as participants. A participant count is a categorical summary: it indicates whether participants were recorded in an outcome category during the stated period. It is different from an event count, which would count every event occurrence, including multiple occurrences in the same participant. The posted group counts should therefore not be read as the total number of adverse-event episodes.

What does a participant count tell the reader?

For each group, the registry gives a number at risk and a number affected for serious and other adverse events. The affected count tells how many participants were recorded in that category, while the at-risk count supplies the group denominator for interpreting that count. These are descriptive summaries. A larger affected count can reflect a higher observed frequency, but a comparison between groups also depends on the denominators and on the uncertainty associated with each estimate. The registry record does not report confidence intervals or an inferential analysis for these outcomes.

In general, a confidence interval describes a range of values compatible with the data under a statistical model and indicates the precision of an estimate. It is useful because point estimates from small groups can be uncertain. No confidence interval is posted for these safety counts, so readers cannot use the registry record to assess their statistical precision in that way. No p-value or adjusted treatment comparison is reported either. This absence does not establish that there is no difference; it means the record does not present an inferential test to evaluate one.

Why distinguish serious and other events?

Seriousness is defined by the event’s consequences or significance, not simply by whether an event is common or uncommon. The registry’s serious-event definition includes death, hospitalization, life-threatening situations, persistent or significant disability or incapacity, and congenital anomaly or birth defect in offspring, along with other events deemed significant. The separate serious-event count therefore answers a different descriptive question from the count of other adverse events. The registry’s categories do not replace examination of event descriptions, severity, timing, or relatedness, none of which is reported in detail for these counts.

General statistical interpretation also depends on the observation period. Participants must have an opportunity to be observed for events before group counts can be compared meaningfully. The endpoint timeframe is defined as beginning at study-drug administration and extending to 281 Days Postdose. The registry does not provide participant-level follow-up duration, censoring information, or details about incomplete follow-up. A time-to-event analysis cannot be inferred from a participant count alone.

What can be concluded from the analysis record?

The registry lists zero analyses. It therefore does not report a formal model, hypothesis test, covariate adjustment, or analysis set beyond the stated As Treated Population definition for the primary outcome. The record identifies randomization and double masking, but the statistical analysis plan, allocation ratio, and methods for handling missing observations are not reported in the registry record. Without those details, it is not possible to determine whether the posted counts were accompanied by prespecified inferential procedures or how any deviations from the intended analysis were handled.

The outcome list also includes pharmacokinetic measures such as AUC, Cmax, clearance, half-life, Tmax, and apparent terminal-phase volume of distribution, plus anti-drug-antibody positivity. These types of outcomes generally require summaries appropriate to their measurement scale and distribution. For example, exposure and concentration measures may be skewed, and a method that assumes symmetric, normally distributed values may not describe them well. General statistical practice may use transformations or distribution-appropriate summaries when warranted, but the methods used for those outcomes are not reported in the registry record. Their results are not posted as analyses in this record.

Multiplicity arises when several outcomes or comparisons are examined: the chance of at least one apparently unusual result can increase if many statistical tests are performed without accounting for the number of tests. That is a general consideration, not a claim about procedures used in this study. Because the registry lists no analyses, it does not indicate which outcomes were formally tested, whether multiplicity adjustments were planned, or whether any exploratory analyses took place. Those details are not reported in the registry record.

Finally, descriptive counts should not be converted into claims about statistical power. Power depends on design assumptions, a chosen effect, and a specified analysis. The registry does not report the trial’s own sample-size justification or a power calculation. Any planning illustration based on an observed effect would be a hypothetical planning exercise, not evidence about the study’s observed power or a substitute for the trial’s analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures, including the primary safety outcome, pharmacokinetic outcomes, and anti-drug-antibody positivity. It lists zero analyses. The statistical plan, hierarchy of secondary outcomes, and any prespecified approach to multiplicity are not reported in the registry record. Multiplicity is a general concern when many outcomes or comparisons are tested: without an appropriate plan, the chance of a nominally notable result arising by chance can increase. The record does not establish whether such testing was conducted or how it would have been handled.

The primary outcome population is described as the As Treated Population, including all randomized participants treated with MEDI7836 or placebo. This description indicates that the outcome is framed around participants who were randomized and received study drug. The registry does not report a separate intention-to-treat analysis, a per-protocol analysis, or the handling of participants who were randomized but not treated. The allocation ratio and analysis populations for the secondary outcomes are also not reported in the registry record.

Missing-data methods are not reported in the registry record. The record does not state whether any outcome observations were missing, how incomplete follow-up was handled, or whether any participants were excluded from particular outcome summaries. It also does not report participant-level follow-up or censoring details. These omissions limit assessment of whether the posted counts reflect complete outcome ascertainment through the stated observation period. They do not justify assuming that data were missing or that follow-up was incomplete; those details are simply not reported.

The registry also does not provide a sample-size justification, interim-analysis information, or a detailed analysis plan. These elements should not be inferred from the phase designation, enrollment, or observed counts.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse-event figures are the affected participant counts, not event-episode totals. The registry records 0 of 8 participants in the placebo group, 0 of 6 in MEDI7836 Dose 1, 0 of 6 in Dose 2, 0 of 6 in Dose 3, and 0 of 6 in Dose 4 as having serious adverse events. The observation period for the primary endpoint was from study-drug administration to 281 Days Postdose.

A recorded zero means no participants in that listed group were counted as affected for this outcome in the posted results. It does not establish that the underlying risk is zero. In general, a study with limited group sizes can observe no events even when an event remains possible, and the amount of uncertainty cannot be assessed fully without an interval estimate. The registry does not report confidence intervals or a formal comparison for these serious-event counts.

The death entries do not contain reported numerical counts; deaths are not reported in the registry record. The absence of a numerical death result should not be interpreted as a confirmed count of zero. The record also does not provide detailed event descriptions or adjudication information for the serious-event endpoint.

12. What the Result Does, and Does Not, Mean

The registry record documents a completed, randomized, double-masked, placebo-controlled study of single-dose MEDI7836 in healthy adults. Its primary safety outcome counts participants with treatment-emergent adverse events and serious adverse events during the period from administration through 281 Days Postdose. The posted results record no participants with serious adverse events in any listed group, and record other adverse events in each group.

These descriptive findings help characterize what was recorded in this study, but they do not establish whether MEDI7836 caused any particular event. The endpoint definition includes events whether or not they were considered related to the medicinal product, and group-specific relatedness assessments are not reported. Counts also do not describe the full clinical course of events, their duration, or whether a participant experienced repeated events.

The results do not establish equivalence between MEDI7836 and placebo. The registry does not report an inferential comparison, confidence intervals, or a prespecified margin for judging equivalence. Nor does a zero serious-event count prove that a serious event is impossible. It means no affected participants were recorded for that category in the posted group results.

The findings are specific to the study population, single-dose approach, routes and timing described in the record, and the stated observation period. They should not be generalized to different populations, dosing patterns, or clinical settings on the basis of this record alone. The registry does not provide detailed results for the listed pharmacokinetic and anti-drug-antibody outcomes, or a complete account of baseline characteristics and participant disposition.

Overall, the record supports a bounded descriptive reading of the safety counts. It does not provide the statistical analyses needed to quantify comparative uncertainty, establish a dose-response pattern, or draw broader conclusions about treatment effects.

13. Why This Trial Matters Statistically

Early-phase studies often have a descriptive safety role alongside evaluation of drug exposure and other pharmacologic characteristics. This record reflects that combination: the primary outcome counts treatment-emergent adverse events and serious adverse events, while the secondary outcomes include several pharmacokinetic measures and anti-drug-antibody positivity. Such outcomes address different questions, and they require distinct interpretive approaches.

Statistically, the record illustrates why counts need context. The affected counts are shown with group denominators, and serious events are separated from other adverse events. That structure makes it possible to describe what was recorded in each group without treating raw counts as directly comparable measures of risk. It also highlights the limits of a sparse event summary: participant counts do not reveal event recurrence, timing, severity within the non-serious category, or relatedness to treatment.

The trial’s randomization and double masking are important design features, but they do not by themselves supply a statistical comparison. The record lists zero analyses and does not report confidence intervals, hypothesis tests, or the analysis plan. This distinction matters for readers: design descriptions explain how a study was organized, while inferential results describe the estimated uncertainty around comparisons. One cannot substitute for the other.

The record also demonstrates the value of transparent reporting. Details such as the allocation ratio, masking roles, missing-data approach, multiplicity plan, dose amounts, and statistical analysis methods are not reported in the registry record. Those details would help readers evaluate the precision and scope of any conclusions. Their absence calls for restraint, not speculation about methods or findings.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry’s posted safety results are limited to group-level participant counts. Event narratives, event onset and duration, recurrence, severity details for other adverse events, and treatment-relatedness assessments are not reported in the registry record. The serious-event outcome has no recorded affected participants in the listed groups, but the record does not give confidence intervals or another measure of uncertainty around those counts.

The registry does not report numerical death counts. It also does not provide detailed participant disposition, outcome completeness, or follow-up information beyond the stated endpoint timeframe. Missing-data handling and censoring methods are not reported, so completeness of observation cannot be assessed from this record.

Key design and analysis details are absent, including the MEDI7836 dose amounts, allocation ratio, randomization procedure, masking roles, sample-size justification, statistical analysis plan, and methods for multiplicity. Although the record lists 13 outcome measures, it lists zero analyses. Results for the pharmacokinetic and anti-drug-antibody outcomes are not reported in the registry record.

The study concerned healthy adults and a single-dose approach. The registry summary describes healthy adult male subjects and healthy adult female subjects of non-childbearing potential, but further population details are not reported. These features limit how far the safety counts can be generalized. The record is informative as a description of posted results, but it does not support a detailed comparative or causal assessment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Assess the Safety of MEDI7836 in Healthy Adults. — NCT02388347.
• Registry record last updated 2017-05-16; status last verified 2017-04.
• Results first posted 2017-04-12.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT02388347 is a completed Phase 1a randomized, double-masked, placebo-controlled, parallel-group study of a single subcutaneous dose of MEDI7836 in healthy adults. The registry reports enrollment of 79, a study start of 2015-03, and primary completion in 2016-01. The primary outcome was the number of participants with treatment-emergent adverse events and serious adverse events from study-drug administration to 281 Days Postdose.

The posted group results record no participants with serious adverse events in the placebo or MEDI7836 groups. Other adverse-event counts are also reported by group. The registry lists pharmacokinetic and anti-drug-antibody outcomes, but lists zero analyses. Detailed inferential results, missing-data methods, and the statistical analysis plan are not reported in the registry record.